This article in the New Jersey Star Ledger explains why Merck’s star witness in the Vioxx trials, Alise Reicin, may have a credibility issue in future trials. Here are excerpts from the article:
Described by her bosses at the New Jersey pharmaceutical company as a “tenacious defender of the Vioxx franchise,” she has been Merck’s most reliable witness in the three trials so far involving the once-popular painkiller.
Now, she’s on trial as much as the drug itself.
That’s because of a bombshell last month from the editors of the New England Journal of Medicine. They accused the authors of a key study on Vioxx of fudging the data, and making the drug look safer than it was. Reicin was a co-author of the Vioxx study, and plaintiffs attorneys say the editorial undercuts her testimony that Merck acted responsibly.
Reicin, a 45-year-old scientist, who lives in Englewood, helped design the clinical trials that led to the drug’s regulatory approval in 1999. And she has consistently provided the scientific underpinning to Merck’s claim it acted in good faith before pulling the drug from the market in September 2004, after a study linked it to an elevated risk of heart attack and stroke.
The medical journal’s editors claim the authors of a Vioxx study named Vigor, published in 2000, failed to mention three heart attacks among those given the painkiller and also deleted other relevant safety information. The heart attacks were significant, the editors say, because they occurred in patients at a low risk of cardiovascular problems.